Suture anchors and method of use

ABSTRACT

An anchoring system for securing tissue to bone includes an implant having a body through which a suture eyelet extends transversely, a suture recess extending along a portion of a length of the body, having a predetermined depth below an outer surface of the body, and a suture pinch ramp disposed at a proximal end of the suture recess. The suture pinch ramp has a depth approximately equal to the predetermined depth at a distal end thereof and sloping outwardly in a proximal direction so that a depth of a proximal end of the suture pinch ramp approaches zero. An insertion member includes an insertion tube and a handle which is engageable with the anchor body to deploy the anchor in a selected bone site.

This application is a divisional of U.S. application Ser. No.13/573,791, entitled Suture Anchors and Methods of Use and filed on Oct.3, 2012, issuing as U.S. Pat. No. 9,402,617 on Aug. 2, 2016, which inturn claims the benefit under 35 U.S.C. 119(e) of the filing date ofProvisional U.S. Application Ser. No. 61/542,688, entitled SutureAnchor, filed on Oct. 3, 2011. All of the foregoing applications arecommonly assigned and expressly incorporated herein by reference, intheir entirety.

BACKGROUND OF THE INVENTION

There are many suture anchor designs on the market today which areintended to secure suture, wherein the suture is passed through softtissue to bone. Preferred methods often use anchors that do not requireplacing knots in the suture to secure the tissue to the anchor. Thisshift has allowed for a simpler, less time consuming procedure. Also,the knots have been shown to be a common source of anchor failure.

However, the knotless anchors have many challenges. Many anchors canchange the tension in the suture during deployment, which requires thesurgeon to estimate how much tension will be added during the finalinstallation step. This can result in under- or over-tensioning of thetissue against the bone. Anchors that allow the suture to be tensionedafter the anchor is implanted can be complicated, with many componentswhich lead to expensive and unreliable anchors. These types of anchorscan have user-assisted tensioning devices that can lead toover-tensioned suture that have the ability to pull the anchor out ofthe bone.

Other anchors that allow the suture to be tensioned prior to implantingthe anchor can leave the sutures with uneven tension. Also, many of theanchors are unable to utilize more than two suture ends and haveundesirable metal components.

There have been many different anchors used t secure suture to bone. Asdescribed above, the knotless anchor designs are preferred due to knotfailures.

The PUSHLOCK™ anchor, marketed by Arthrex, is a two-part anchor. The tipof the anchor has an eyelet through which the suture legs are loaded.This tip is placed at the bottom of a hole drilled into the bone. Atthis point, the surgeon may adjust the tension on the suture, therebypulling the tissue closer to the surface of the bone. Since the sutureis tensioned all at once, without any engagement with the hole when therear portion of the anchor is driven into the hole, the tension may notbe correct. Once the rear portion of the anchor is in the hole, thesuture tension cannot be adjusted.

Smith and Nephew market the KINSA™ suture anchor. This anchor is aknotless design made of PEEK (polyether ether ketone) which is tappedinto a pre-drilled hole in the bone. The anchor is preloaded with suturetied in a one-way sliding knot within the anchor body, which allows thesurgeon to adjust the tension after the anchor has been deployed. Thiscannot utilize suture that is already passed through tissue and only canprovide a simple stitch in the tissue.

The POPLOK™ by Conmed Linvatec is another knotless anchor. It is a twopiece polymer anchor that has the ability of accepting and tensioningthe suture individually prior to locking the suture to the anchor.However, the anchor has multiple pieces that can fail.

The VERSALOK™ by Mitek is also a knotless anchor. It is a two piecepolymer and metal design that has the ability of accepting andtensioning the suture individually prior to locking the suture to theanchor. It does have multiple parts forming the anchor and the innermember is metallic.

The CUFFLINK™ Knotless and CUFFLINK SP™ Knotless suture (self punchingwith metal tip) anchors, also marketed by Mitek, are fabricated of PEEK,using a one-piece polymer design without the employment of any metal.The design allows the anchor to accept more than two suture ends, andeach of these ends can be tensioned or have tension releasedindividually by hand, prior to final anchor deployment, providing thesurgeon the ability to achieve the desired tension on each suture. Theanchor may also accept tissue (such as a tendon, ligament, zenograft,allograft, or collagen scaffold) with or without suture, enabling adirect tissue to bone repair. The metal tip version allows the anchor tobe malleted directly into the bone without the need for a pilot hole.Finally, the design incorporates a metal deployment device to providestrength to the anchor during deployment, thereby reducing breaking ofthe anchor.

SUMMARY OF THE INVENTION

The present invention provides a suture or tissue anchor which isintended to secure suture or tissue to bone. There are many soft tissueto bone repair procedures, such as rotator cuff, SLAP (Superior Labraltear from Anterior to Posterior), and Bankart lesion repairs, orreconstruction of labral tissue to the glenoid rim, in which a surgeonneeds to secure tissue in close contact with bone. Often the bonesurface is roughened, and when tissue is pulled into intimate contact,the body's healing response will fuse the tissue and bone together. Thissuture is then passed through the soft tissue at the desired location,and the suture is secured to the anchor by tying a knot. Other methodsinclude passing suture through the tissue first and then fastening theanchor and suture to the bone without knots.

More particularly, there is provided in one aspect of the presentinvention an anchoring system for securing tissue to bone, whichcomprises an implant having a body which includes a suture eyeletextending transversely therethrough, a suture recess extending along aportion of a length of the body, having a predetermined depth below anouter surface of the body; and a suture pinch ramp disposed at aproximal end of the suture recess. The suture pinch ramp has a depthapproximately equal to the predetermined depth at a distal end thereofand sloping outwardly in a proximal direction so that a depth of aproximal end of the suture pinch ramp approaches zero.

Preferably, the implant further comprises external surface features forsecuring the implant within surrounding bone. These external surfacefeatures comprise bone barbs. Suture barbs are disposed on the outersurface of the body at a proximal end thereof, for clamping suture ortissue between the outer surface of the body and adjacent bone. Bonedisplacement tabs are disposed on a distal portion of the implant body,for displacing bone distal to suture for allowing optimal suture slidingduring initial deployment of the anchor.

An inner cavity is provided in the anchor body, having an opening at aproximal end of the anchor body for receiving an insertion device. Theanchoring body further comprises a suture cleat adjacent to the suturepinch ramp.

The anchoring system further comprises an insertion member which isengageable with the anchor body to deploy the anchor in bone. Theinsertion member comprises a proximal handle portion and an insertiontube connected to a distal end of the handle portion. A suture pulleyrod is extendable from and retractable into a distal end of theinsertion tube. A pair of cleat retainers are provided on a distal endof the pulley rod, wherein a gap is disposed between the pair of cleatretainers. A rotatable knob is disposed on the handle portion forretracting and extending the pulley rod relative to the insertion tube.A knob release slide disposed on the handle.

In another aspect of the invention, there is disclosed a method forsecuring soft tissue to bone, which comprises steps of driving animplantable anchor having a body distally into a desired bone site,using an insertion device, to a predetermined initial deployment depth,and applying pressure to suture or tissue disposed between the anchorbody and adjacent bone, using a recess disposed on an outer surface ofthe body and a pinch ramp also disposed on the outer surface of thebody, proximal to the suture recess. Additional steps include tensioningfree ends of the suture or tissue disposed between the anchor body andadjacent bone to a desired level, withdrawing a pulley rod proximallyinto an insertion tube comprising a portion of the insertion device, anddriving the implantable anchor a further distance distally into the bonesite to finally deploy the anchor. The suture or tissue is pinchedbetween barbs on an outer surface of the implant body and adjacent boneand also between cleats on both sides of the anchor body to lock thesuture or tissue in place. Further inventive method steps includewithdrawing the pulley rod from the anchor body and releasing theinsertion device therefrom; and trimming the free suture ends tocomplete the procedure.

In still another aspect of the invention, there is provided an anchoringsystem for securing tissue to bone, which comprises an insertion memberwhich is engageable with an anchor body to deploy the anchor body inbone. The insertion member comprises a proximal handle portion, aninsertion tube connected to a distal end of the handle portion, and asuture pulley rod extendable from and retractable into a distal end ofthe insertion tube. A pair of cleat retainers are disposed on a distalend of the pulley rod, wherein a gap is disposed between the pair ofcleat retainers. A rotatable knob is provided on the handle portion forretracting and extending the pulley rod relative to the insertion tube,and a knob release slide is disposed on the handle.

The invention, together with additional features and advantages thereof,may best be understood by reference to the following description takenin conjunction with the accompanying illustrative drawing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-4 are isometric views of an implantable anchor constructed inaccordance with the principles of the present invention, illustratingthe anchor from four different perspectives;

FIG. 5 is an elevational view of the anchor of FIGS. 1-4;

FIG. 6 is an elevational view similar to FIG. 5, from an opposedorientation;

FIG. 7 is an isometric view of the insertion system of the presentinvention;

FIG. 8 is an isometric view similar to FIG. 7 illustrating the assembledinsertion system and anchor of the present invention in position to bedeployed;

FIG. 9 is an isometric view similar to FIG. 8, wherein the assembly isbeing inserted into a desired bone location;

FIGS. 10-13 are isometric views illustrating the insertion system of thepresent invention, including the handle portion;

FIG. 14 is an elevational view illustrating a first step of a method ofusing the present invention;

FIG. 15 is an isometric view showing the same step as that shown in FIG.14;

FIG. 16 is an elevational view similar to FIG. 14 with the sutureremoved for clarity;

FIG. 17 is an isometric view similar to FIG. 15 with the suture removedfor clarity;

FIG. 18 is an elevational view showing a second step of the describedinventive method;

FIG. 19 is an isometric view of the step illustrated in FIG. 18;

FIG. 20 is an elevational view similar to FIG. 18, with the sutureremoved for clarity;

FIG. 21 is an isometric view similar to FIG. 19, with the suture removedfor clarity;

FIG. 22 is an elevational view showing a third step of the describedinventive method;

FIG. 23 is an isometric view of the step illustrated in FIG. 2

FIG. 24 is an elevational view similar to FIG. 22, the suture removedfor clarity;

FIG. 25 is an isometric view similar to FIG. 23, with the suture removedfor clarity;

FIG. 26 is an elevational view of the anchor of the present inventionshowing a step which is performed prior to final deployment of theanchor;

FIG. 27 is an elevational view similar to FIG. 26, showing theillustrated step from a different orientation;

FIG. 28 is an elevational view illustrating the first step of theinventive method which is also shown in FIGS. 14-17, with the sutureremoved for clarity;

FIG. 29 is an elevational view similar to FIG. 28, illustrating thesecond step of the inventive method which is also shown in FIGS. 18-21,with the suture removed for clarity;

FIG. 30 is an elevational view similar to FIGS. 28 and 29, illustratingthe third step of the inventive method which is also shown in FIGS.22-25, with the suture removed for clarity;

FIG. 31 is an elevational view similar to FIG. 30, showing the proximalwithdrawal of the suture pulley rod in accordance with the method of thepresent invention; and

FIG. 32 is an elevational view similar to FIGS. 28-31, showing the finalcompleted deployment of the inventive anchor.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The inventive system and methods disclosed herein comprise asimple-to-insert suture anchor which allows adjustment of suture ortissue tension prior to deployment, does not change the tension on thesuture or tissue (and as a result, the captured tissue) when it isdeployed, does not require a knot to secure the suture or tissue, andaccepts multiple suture ends.

Referring now more particularly to the drawings, there is shown in FIGS.1-6 a suture anchor 10 constructed in accordance with the principles ofthe present invention. The anchor 10 comprises a body 12 having aplurality of proximal suture barbs 14, as well as bone barbs 16. Aportion of the outer surface of the body 12 comprises a suture recess18. An inner cavity 20 (FIG. 3) is provided for accommodating a suturepulley rod, to be described below. The distal end of the anchor body 12includes bone displacement tabs 22.

Within the suture recess 18 are disposed a suture pinch ramp 24, asuture cleat 26, and a suture eyelet 28, which extends transverselythrough a width of the body 12 so that it is open to opposing sides ofthe body.

Now with reference to FIGS. 7-13, the insertion system 30 for the anchor10 will be described. The insertion system or inserter 30 comprises asuture pulley rod 32 (FIG. 7), suture cleat retainers 34 on the distalend of the pulley rod 32 (also FIG. 7), and an insertion tube 36. Insome embodiments, an optional metal distal tip 38 (FIG. 9) may beemployed.

A handle portion 40 of the insertion system 30 is illustrated in FIGS.10-13. The handle portion 40 comprises a knob release slide 42 and aproximal knob 44.

The anchor 10 has a number of features that are important to itsinnovative function. For example, the suture barbs 14 pinch the sutureagainst the surrounding bone when the implant is deployed. The remainingbarbs are the bone barbs 16, distal to the suture barbs 14, function toengage the bone during the initial and final deployment. The suturerecess 18, because of its recessed profile relative to remainingportions of the outer surface of the body 12, allows the suture to slidebetween the anchor body and adjacent bone during the initial deployment.The inner cavity 20 for the suture pulley rod 32, allows for the metalsuture pulley rod 32 to support the anchor during initial deployment.The bone displacement tabs 22 displace the bone distal to the suture toallow for optimal suture sliding during initial deployment.

The suture pinch ramp 24 helps to maintain tension during individualtensioning of the suture. It is configured to slope outwardly in aproximal direction, so that its distal end is at a depth approximatingthe depth of the suture recess 18 and its proximal end is at the outersurface of the implant body 12, i.e., a depth of approximately zero. Thesuture cleat 26 pinches the suture to increase the suture pulloutstrength of the construct. The suture eyelet 28 allows for one or moresuture ends to be placed in the implant. Each suture end is individuallytensionable, as well be described below. Though the tip 46 of the anchor10 is illustrated as being closed, as shown in FIG. 9, the optionalmetal tip 38 may be added to the anchor 10 to allow for the anchor to beinserted directly into bone without the requirement of a pilot hole.

The insertion system 30, as well, has several important features whichcontribute to the innovative function of Applicant's inventive system.In particular, the suture pulley rod 32, in the initial deploymentstage, allows the suture to move freely in the suture eyelet 28, bypreventing the suture from entering the suture cleat 26. The pulley rod32 also increases the strength of the anchor 10 by extending to thedistal tip 46 of the anchor body 12 during initial deployment. Theinsertion tube 36, as well as the pulley rod 32, transmits the insertionforce from a mallet to the anchor during initial deployment. Rotation ofthe proximal knob 44 actuates a mechanism that retracts the pulley rod32 between initial and final deployment stages. The knob release slide42 releases the knob 44 to allow for removal of the inserter 30 afterfinal deployment. The suture cleat retainers 34 maintain a set gap inthe suture cleat 26 during final deployment.

The remaining FIGS. 14-32 will now be referenced in connection with adescription of methods of using the inventive system to deploy an anchor10 in bone 48.

To deploy the anchor 10 in a suitable bone site, suture 50 is firstpassed through soft tissue (not shown) requiring repair. Viewing, forexample, FIG. 19, the suture loops 51 in the suture 50 would normally beoccupied by the soft tissue to be approximated against the bone 48, butthat tissue is not shown, for clarity. Alternatively, soft tissue itselfmay be anchored directly in place within the desired bone site 48,rather than using suture 50, in which case the tissue is manipulated inthe same way as the suture to be described in this explanation. For thisreason, though the term “suture” is used throughout this specification,for convenience, the term should be considered sufficiently broad toinclude other media having similar functional characteristics, includingsoft tissue itself. A pilot hole 52 (FIGS. 9 and 28) is drilled orpunched into the attachment site (bone 48), through the cortical bonelayer 54 and into the cancellous bone layer 56. In some circumstances,the optional metal distal tip 38 may be employed (FIG. 9), in which casethe step of drilling a pilot hole is unnecessary. The suture is then fedthrough the suture eyelet 28, as shown in FIGS. 14 and 15, directly orwith a snare. One or more suture ends 58, 60 (FIG. 15) may be placedthrough the eyelet 28.

With the anchor 10 and attached inserter 30 positioned at the desiredbone site, as shown in FIGS. 14 and 15, initial deployment of the anchor10 can occur. It should be noted that FIGS. 16 and 17, and FIG. 28,illustrate the same step as FIGS. 14 and 15, with the suture 50 removedfor clarity. To initiate this initial deployment, a mallet is drivenagainst the proximal end of the handle portion 40 to drive the anchor 10distally to its initial deployment position, as shown in FIGS. 18 and19, and also in FIGS. 20 and 21, and 29, with the suture again removedfor clarity. At this juncture, the suture recess 18 is acting to applypressure to the sutures or tissue 50 disposed between the outer surfaceof the anchor body 12 and the adjacent bone surface, as well as againstthe suture pinch ramp 24. This pressure maintains the tension on thesuture 50.

The free suture ends 58, 60 may be individually tensioned around thesuture pulley rod 32 to approximate the tissue within the suture loops51 up against the anchor and repair site and its surrounding bone 48. Ifthe suture is over-tensioned, a probe may be used to loosen the tissueside of the suture.

Once the desired tension is achieved, the suture pulley rod 32 is pulledproximally into the insertion tube 36, by rotating the threaded proximalknob 44 on the handle portion 40 until further rotation is prevented.When the tube 36 is retracted by the rotation of knob 44, the gap of thesuture cleat 26 is exposed. At this point, the suture cleat retainers 34are in position on either side of the suture cleat 26. This retractedpulley rod position is illustrated in FIGS. 26 and 27, which is theposition required prior to the final insertion step. As noted above, thesuture cleat 26 is exposed and held open by the suture cleat retainers34, which thus allow the suture to pull into proper position duringfinal insertion.

At this juncture, the final deployment steps are initiated, as shown inFIGS. 22 and 23, and also in FIGS. 24 and 25, and 30, wherein the suture50 has been removed for clarity. With the gap of the suture cleat 26maintained by the suture cleat retainers 34, the inserter handle 40 isagain malleted, directing insertion force into the insertion tube 36until the anchor 10 rests below the surface of the bone, as shown inFIG. 30. Because the suture 50 has maintained an equal distance from thesurface of the bone, post-tensioning and post-final deployment, thetension in the suture 50 is maintained. If additional tension isrequired, the anchor can be malleted deeper into the bone, pulling thesuture ends with it, thereby increasing tension.

The suture 50 is now pinched between the suture barbs 14 and the bone onthe tissue side of the anchor, as shown in FIG. 23. It is also pinchedbetween the suture cleats 26 on both sides of the anchor body 12.Finally, the free suture ends 58, 60 are pinched between the suturebarbs 14 and the bone opposite to the tissued side of the anchor.

The suture pulley rod 32 may now be pulled out of the anchor body 12, asshown in FIG. 31, releasing the inserter 30 by actuating the knobrelease slide 42 to allow the threaded knob 44 to be free to rotate. Theknob 44 is then rotated until the inserter is released from the implant.At this juncture, the free suture ends can be cut, as shown in FIG. 32,which completes the repair.

Accordingly, although an exemplary embodiment of the invention has beenshown and described, it is to be understood that all the terms usedherein are descriptive rather than limiting, and that many changes,modifications, and substitutions may be made by one having ordinaryskill in the art without departing from the spirit and scope of theinvention, which is to be limited only in accordance with the followingclaims.

1.-18. (canceled)
 19. An anchoring system for securing soft tissue tobone, the anchoring system comprising: an anchor that includes a distalend, a proximal end, and a suture eyelet formed in the anchor betweenthe distal end and the proximal end of the anchor, wherein at least thedistal end of the anchor is positionable inside a bone; a suture passingthrough the suture eyelet; and a delivery rod received in the anchorthrough an opening in the proximal end of the anchor; wherein thedelivery rod is movable distally inside the anchor to a first positionin which the positioning of the delivery rod permits the suture to slidethrough the suture eyelet yet blocks the suture from entering a suturecleat that is positioned proximally of the suture eyelet in the anchor,and wherein the delivery rod is further movable back through the anchorproximally to a second position in which the delivery rod no longerblocks the suture from entering the suture cleat.
 20. The anchoringsystem of claim 19, wherein the delivery rod extends to the distal endof the anchor in the first position.
 21. The anchoring system of claim19, wherein the delivery rod is part of an insertion member that has aproximal handle portion.
 22. The anchoring system of claim 19, whereinthe suture cleat has a reduced width relative to the suture eyelet. 23.The anchoring system of claim 19, wherein the delivery rod includes apair of projections at a distal end of the delivery rod.
 24. Theanchoring system of claim 23, wherein, in the first position, the pairof projections are positioned on opposite sides of the suture eyelet.25. The anchoring system of claim 23, wherein, in the second position,the pair of projections are positioned on opposite sides of the suturecleat.
 26. The anchoring system of claim 23, wherein the pair ofprojections hold the suture cleat open in the second position.
 27. Theanchoring system of claim 19, wherein the anchor is a one-piece anchorbody.
 28. The anchoring system of claim 19, wherein the suture eyeletextends transversely through the anchor from a first side of the anchorto a second side of the anchor.
 29. An anchoring system for securingsoft tissue to bone, the anchoring system comprising: an anchor thatincludes a distal end, a proximal end, a suture eyelet, and a suturecleat, the suture eyelet formed in the anchor proximal of the distal endof the anchor, the suture cleat formed in the anchor proximal of thesuture eyelet, wherein at least the distal end of the anchor ispositionable inside a bone; a suture extending transversely through theanchor; and a delivery rod received in the anchor through an opening inthe proximal end of the anchor; wherein the delivery rod is movableinside the anchor to a first delivery position in which the delivery rodoccupies the suture cleat to block the suture from entering the suturecleat while permitting the suture to slide through the anchor throughthe suture eyelet, and wherein the delivery rod is further movableinside the anchor from the first delivery position to a second deliveryposition in which the delivery rod no longer occupies the suture cleatso that the suture can enter the suture cleat.
 30. The anchoring systemof claim 29, wherein the delivery rod extends to the distal end of theanchor in the first position.
 31. The anchoring system of claim 29,wherein the delivery rod is part of an insertion member that has aproximal handle portion.
 32. The anchoring system of claim 29, whereinthe suture cleat has a reduced width relative to the suture eyelet. 33.The anchoring system of claim 29, wherein the delivery rod includes apair of projections at a distal end of the delivery rod.
 34. Theanchoring system of claim 33, wherein, in the first position, the pairof projections are positioned on opposite sides of the suture eyelet.35. The anchoring system of claim 33, wherein, in the second position,the pair of projections are positioned on opposite sides of the suturecleat.
 36. The anchoring system of claim 33, wherein the pair ofprojections hold the suture cleat open in the second position.
 37. Theanchoring system of claim 29, wherein the anchor is a one-piece anchorbody.
 38. The anchoring system of claim 29, wherein the suture eyeletincludes a first opening and a second opening in an outer side wall ofthe anchor.